These guidelines were developed to implement the Office of Management
and Budget (OMB) Guidelines and the Department of Health and Human Services
(HHS) guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility,
and Integrity of Information Disseminated by Federal Agencies, hereafter
referred to as the OMB Information Quality Guidelines and the HHS Part I:
Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility,
and Integrity of Information Disseminated to the Public. This report provides
the information quality guidelines for the National Institutes of Health
(NIH), and explains how these guidelines will ensure and maximize the quality,
objectivity, utility, and integrity of information, including statistical
information, disseminated by NIH to the public. This report also details
our administrative mechanisms for allowing affected persons to seek and obtain
appropriate correction of information maintained and disseminated by the
NIH.

The OMB Information Quality Guidelines can be found in the Federal Register, September 28, 2001
The guidelines apply primarily to the dissemination of substantive information
(e.g., scientific reports, articles, studies, summaries, speeches, official
expert opinions, brochures, statistical information, or compendiums) rather
than information pertaining to basic agency operations. Such information
can be in any media -- printed, electronic, audiovisual, and the like --
and must be authored or issued by the agency or its contractors, and represent
our view.

NIH will ensure that disseminated information meets the standards
set forth in the OMB, HHS, and NIH guidelines. It is NIH's policy to ensure
and maximize the quality, objectivity, utility, and integrity of the information
it disseminates to the public. We strive to provide information that is accurate,
reliable, clear, complete, unbiased, and useful. The quality assurance process
begins at the inception of the information development process. NIH is committed
to integrating the principle of information quality into every phase of information
development, including creation, collection, maintenance, and dissemination.
Each federal agency is already required to demonstrate the "practical utility"
of a proposed collection of information in its Paperwork Reduction Act (PRA)
submission, i.e., for draft information collections designed to gather information
that the agency plans to disseminate. NIH will demonstrate in its PRA clearance
packages that each such draft information collection will result in information
that will be collected, maintained, and used in a way consistent with OMB,
HHS, and NIH information quality guidelines. NIH intends to make use of the
PRA clearance process to help improve the quality of information that we
collect and disseminate, and to ensure that it complies with all applicable
guidelines. The standards to which NIH shall adhere include the following:
.

Information should be objective in substance and presentation. Objectivity
means ensuring that information is accurate, reliable, and unbiased and that
information is presented in an accurate, clear, complete, and unbiased manner.
If analytic results have been subject to formal, independent, external peer
review, the information may generally be presumed to be of acceptable objectivity.
However, this presumption is refutable based on a persuasive showing by the
petitioner in a particular instance. As described in more detail in Section
V, NIH works to maintain objectivity through existing review and clearance
procedures, and the peer review of disseminated information.

Information should be responsive to its intended users, including
the public. NIH strives to stay informed of user needs, through user feedback,
consultation with advisory committees and peer review groups, and conference
participation. Appropriate public access to government information and data
play a useful role in improving the overall quality of information disseminated
by federal agencies.

The integrity of information should be protected. As described
in more detail in Section V.3, NIH ensures the integrity of its data and
information products through the enforcement of rigorous controls that protect
against unauthorized access, revision, or corruption. Some of the controls
used at NIH include access control, user authentication, encryption, access
monitoring, provision of unalterable electronic content, and audit trails.

I. Agency Mission

Founded in 1887, today NIH is one of the world's
foremost medical research centers, and the Federal focal point for medical
research in the U.S. NIH, comprised of 27 separate Institutes and Centers,
is 1 of 8 health agencies of the Public Health Service, which, in turn, is
part of the U.S. Department of Health and Human Services (HHS).

Simply described, the goal of NIH research is to acquire new knowledge
to help prevent, detect, diagnose, and treat disease and disability, from
the most rare genetic disorder to the common cold. The NIH mission is to
uncover new knowledge that will lead to better health for everyone. NIH works
toward that mission by: Conducting research in its own laboratories; supporting
the research of non-Federal scientists in universities, medical schools,
hospitals, and research institutions throughout the country and abroad; assisting
in the training of research investigators; and promoting communication of
medical and health sciences information.

More than 80% of NIH’s funding supports non-Federal researchers working
in universities, medical centers, hospitals, and research institutions throughout
the country and abroad (collectively referred to as extramural research),
and about 10 percent is allocated to in-house research laboratories located
on the NIH campus and several off-campus sites (referred to as intramural
research). NIH has approximately 18,000 employees, approximately 3,000 of which have
doctoral or medical degrees.

It is NIH policy to make available to the public the results and
accomplishments derived from the activities that it funds. Therefore, NIH-funded
intramural and extramural investigators are expected to make the results
and accomplishments of their activities available to the research community
and to the public at large, and to effect their timely transfer to industry
for commercialization.

NIH Policy Issuances

NIH is organized into Institutes and Centers (ICs), each with its own
mission and functions, separate appropriations, and statutory authorities.
Although these ICs may have different administrative procedures in place,
they operate under the same general NIH policies and requirements. The NIH
Policy Manual System is the formal mechanism for issuing NIH policy. The
system is comprised of a series of NIH Manual Chapters. It provides an organized,
central repository of information that is accessible to all NIH employees.
Individual IC's have the flexibility to incorporate the quality and accountability
requirements of Federal and NIH guidelines into their own information resource
management and administrative practices in the most applicable manner.

Responsible Official

At NIH, the Associate Director for Communications, who is also the
Director of the Office of Communications and Public Liaison (OCPL) in the Office of the Director, has the responsibility for implementing the NIH Information Quality Guidelines, while the Office of Science Policy (OSP), will have overall responsibility for implementing the Guidelines, and will work collaboratively with the
ICs. OSP is the central office for policy related issues at NIH. As such, they have
taken the lead across the NIH for Information Quality, as it relates to NIH programs, issues, and accomplishments
to the public and public interest groups and, to a lesser extent, to the
scientific community and the medical professions. The OSP, is also the point of contact is between the ICs and the Office of the Assistant Secretary for Public
Affairs in the HHS. The OCPL, is the coordinating office or central source
for NIH IC matters related to publications, including printing, HHS/PHS/NIH
clearance and review procedures, Joint Committee on Printing, U.S. Congress,
and Government Printing Office printing and binding regulations, and copyright
rules. Among its many activities, the office produces and distributes a number
of publications that highlight NIH research results and scientific advances;
provides print, radio, and TV coverage of NIH news and activities; produces
the NIH Record; and publishes consumer health information, primarily in a
newsletter for the press and public entitled The NIH Word on Health. OCPL also supports and coordinates the principal NIH Web site (www.nih.gov)
with direct responsibility for several major areas of the NIH home page that
address the special needs of healthcare professionals, patients, members
of the press, the public, and employees. It manages the NIH Web Coordinating
Committee that provides leadership for the design and content of the NIH
Web site, including reviewing new Web sites before they are integrated into
the structure of the NIH home page; works with other relevant offices and
committees in establishing operational standards and guidelines for Web sites
at NIH; and manages the responses to electronic mail sent to the NIH home
page.

It is likely that any formal complaint regarding information quality
will go first to the IC or Office responsible for originating the information.
It is therefore essential that the relevant components of NIH work cooperatively
with OCPL and OSP to ensure a timely and appropriate response to any complaints.

As the lead offices for NIH Information Quality, OCPL and OSP responsibilities include:

Developing policies and procedures to effectively meet the requirements of the OMB Information Quality Guidelines;

Providing information and/or training to NIH staff on their
responsibilities in meeting Federal requirements and NIH policies on ensuring
the quality of information disseminated to the public;

Assisting in the review of information quality complaints;

Reviewing the proposed IC response for appropriateness, and assisting in finalizing a response;

Establishing a tracking database for complaints, with information
on the type of complaint and its disposition and any resolution or corrective
action taken;

Submitting an annual report on behalf of NIH to HHS with the
number and types of complaints, and the actions taken, in time for the HHS
to report to OMB by January 1 (beginning in 2004);

Posting on the OCPL Web site any further clarifications, guidelines,
and Frequently Asked Questions (FAQs) about handling NIH information complaints;

Making available examples of typical complaints and appropriate responses collected from IC reports.

II. Scope of Applicability of Guidelines for Agency

The OMB Information
Quality Guidelines require NIH to evaluate and identify the types of NIH
information that will be subject to the Guidelines. This section identifies
the types of information covered by the Guidelines, and also lists the types
of information that are exempt. The NIH Office of the General Counsel originally
reviewed this information on November 27, 2001 and considered NIH's interpretation
to be consistent with the intent of the law.

The pre-dissemination review described in the guidelines only applies
to official information (with the NIH imprimatur) that is released on or
after October 1, 2002. The administrative mechanism for correction applies
to information that the agency disseminates on or after October 1, 2002,
regardless of when the agency first disseminated the information. They apply
to information in all media — printed, electronic, audiovisual, verbal, and
other. The Guidelines focus primarily on the dissemination of substantive
information (i.e., reports, studies, summaries) rather than information pertaining
to basic agency operations. Information that is disseminated at the request
of NIH or with specific NIH approval through a contract or a grant is subject
to these Guidelines. Examples are provided below of the kinds of information
that the NIH considers to be covered and not covered by the OMB Information
Quality Guidelines. Although information that is not covered by the OMB Guidelines
are not subject to the new administrative complaint procedures, the information
is still subject to the usual NIH internal review procedures for accuracy
and quality.

NIH Information Covered by the OMB Guidelines

Scientific research papers, books, journal articles, and similar authoritative
materials, unless they have disclaimers alerting the audience that they do
not represent official views of the NIH

Other official reports, brochures, documents, newsletters, fact sheets, electronic
documents, and audiovisual productions (i.e., a unified presentation, developed
according to a plan or script, containing visual imagery, sound, or both,
and used to convey information)

Editorials, commentaries, letters-to-the-editor, only if NIH staff representing official NIH viewpoints provides them

Oral information, including speeches, interviews, expert opinions,
only if representing NIH's views, official positions, or policies

Information intended solely for intra- or interagency use or sharing of Government information

Responses to requests for agency records under the Freedom of Information
Act (FOIA), the Privacy Act, the Federal Advisory Committee Act, or other
similar laws

Information relating solely to correspondence with individuals or persons

Press releases that support the announcement or give public notice of information that NIH has disseminated elsewhere

Information intended for public filings, subpoenas, or adjudicative
processes involving specific parties (There are well-established procedural
safeguards and rights to address the quality of adjudicatory decisions and
to provide persons with an opportunity to contest decisions. These guidelines
do not impose any additional requirements on agencies during adjudicative
proceedings and do not provide parties to such adjudicative proceedings any
additional rights of challenge or appeal.)

Opinions where the agency's presentation makes it clear that what
is being offered is personal opinion rather than fact or the agency's views

III. Types of Information Disseminated by NIH to the Public

Each
year, NIH components produce 400 or more publications of various types, and
about 140,000 static Web pages. All publications that carry the NIH imprimatur,
i.e. are considered official NIH publications or releases, must follow NIH
policy and procedures for preparation, review, approval, and distribution
(see Section V).
The types of information disseminated by NIH to the public include the following,
however, the OMB guidelines are not directly applicable to all of the information
in these categories (See Section II):

Program Reviews, Analyses, and Evaluations.

This category includes research project descriptions [e.g., abstracts
of funded grant proposals available through the NIH Computer Retrieval of
Information on Scientific Projects (CRISP) database2],
bibliographies, collection of abstracts, reviews, and recurring reports.
Summaries of research findings are routinely shared with interested parties
(e.g., the public, other researchers, the press, Congress). These findings
can be released in the form provided by the investigator, or the investigator-supplied
information can be used as the basis of a narrative describing research progress
in a particular program area. Syntheses of research findings are used for
many purposes, including in meeting annual reporting requirements, such as
the Government Performance and Results Act (GPRA). Highlights of research
findings are posted on the NIH Web site, and can be found in testimonies
and speeches by NIH staff in many venues, including annual Appropriations
Hearings, presentations on NIH funding opportunities, and literature reviews.

Grants and Funding Opportunities.

The NIH Guide for Grants and Contracts
(http://grants.nih.gov/grants/guide/description.htm)
is the official document for announcing the
availability of NIH funds for biomedical and behavioral research and research
training, and disseminating policy and administrative information. Current
and past issues of the NIH Guide for Grants and Contracts are available on the NIH Web site, along
with other information on grants policy, peer review, award data, research
contracts, application forms, and the RePORT database, and links to each of the
27 ICs.

Scientific Reports.

Can be in the form of a book, chapter of a book or textbook, monograph,
journal article, proceedings, or the like. These are generally authored or
co-authored by NIH staff scientists as part of their official duties, or
may be authored by working groups convened by the NIH. Ordinarily first report
of any scientific research results or other professional findings is made
by publication in a scientific or professional journal; or presentation at
a meeting of a professional organization.3

Statistical Compendiums.

Examples of statistical compendiums include annual appropriations
by IC, employment data (e.g., numbers of staff and staffing by professional
degree), and data books produced by statistical agencies (e.g., Census Bureau,
NCHS) under contract to NIH (e.g., Aging World, 65+ in America).
Also prominent is the annual table showing research dollars allocated by
disease entitled Funding for Research Areas of Interest released by the NIH
Budget Office. The estimated spending amounts are self-reported by individual
ICs. Although ICs are requested to use consistent methods across years, estimation
methods and assumptions across ICs may not be consistent.

Guidelines or Authoritative Health Information.

This type of information is issued after careful review and deliberation
of available scientific evidence, usually with the assistance of a panel
of outside experts, and is generally associated with a formal meeting or
consensus panel specifically convened for the purpose. Prime examples are
NIH Consensus Statements and State of the Science Statements issued as part
of the NIH Consensus Development Conference program managed by the NIH Office
of Medical Applications of Research (see Section V.2.c),
and the Report on Carcinogens prepared by the National Toxicology Program
at the National Institute of Environmental Health Sciences, NIH (see Section
V.2.d).

Editorials, Commentaries, Letters-to-the-Editor.

Only if they are provided by NIH staff representing official NIH viewpoints.

Consumer Information.

NIH provides a number of resources for the general consumer to learn
about health conditions, participate in research studies, look up drug information,
contact the NIH, find health literature references, and read about special
programs. A considerable amount of this information is developed and distributed
through IC-established clearinghouses, some of which are required by law.
Other sources of consumer information include MedLine Plus, a health database
maintained by the NIH's National Library of Medicine; the NIH Research Matters,
a newsletter of articles on health maintenance and prevention; A-Z topic
index with primary Institute contact; PubMed, a comprehensive database of
article titles and abstracts; Clinical Trials database on medical studies
around the country; a MEDLINEplus guide to over 9,000 medications; and much
more. Other information provided to the public includes Information about
NIH, Visitor Information, Job Opportunities, Employee Directory, and FOIA
provisions.

Science Education Materials and Training Modules.

NIH provides science education materials as well as training modules
for clinical investigators and extramural scientists. The NIH Curriculum
Supplement Series are interactive teaching units that combine cutting-edge
scientific research discoveries with state-of-the-art instructional materials
for grades K-12. Examples of training aids available to extramural researchers
include Human Subjects Assurance Training, and various self-instructional
guidebooks and videotapes.

Press Releases.

NIH press releases are archived 2 weeks after their release date
and made available on the NIH Web site. Interested persons can subscribe
to receive these press releases via email.

IV. Types of Dissemination Methods

NIH information is disseminated in many mediums, with the following four being most common:

formal speeches, oral presentations, interviews,
or commentaries for publication or broadcast; letters-to-the-editor or correspondence
likely to result in similar publications.

Audio-Visual --

broadcast scripts, audio or videotapes,
and videocasting. The Center for Information Technology (CIT) makes special
NIH events, seminars, and lectures available to viewers on the NIH network
and the Internet from the VideoCast Web site.

Electronic --

The NIH Web site is the most popular Government
Web site after the Internal Revenue Service, and has about 3 million unique
visitors per month. The NIH Web site is recognized as one of the most respected
and trusted sources for authoritative health information (Consumer Reports, January 2002; Forbes.com review, September 10, 2001; Business Wire,
January 29, 2001). The NIH Web site is not just one site, but also a large
collection of sites residing on over 150 servers with over 140,000 static
pages that are crawled and indexed on public servers. Some areas are updated
daily, while others may not be updated for weeks or months.

V. Agency Quality Assurance Policies, Standards, and Processes for
Ensuring the Quality of Information Disseminated to the Public

Overview

All NIH documents and audiovisuals must be prepared in accordance with
professional and ethical standards, as well as generally accepted standards
of good taste. They must be appropriate for dissemination by this Federal
agency, and must undergo appropriate review and approval prior to release.
NIH must adhere to the laws and regulations applying to publications and
audiovisuals, including OMB Information Quality Guidelines, the HHS Printing
Handbook, and relevant NIH Manual chapters. NIH efforts to ensure and maximize
information quality begin at the preparation stage, and continue through
the review and approval stages. Existing NIH policies developed in concert
with Federal computer security laws provide appropriate security safeguards
to ensure integrity of NIH documents, i.e., ensure that the information is
protected from unauthorized access, revision, corruption, or falsification.

The NIH has many quality control measures embedded in the scientific
process to ensure that the information disseminated is of the highest quality.
NIH grant applications undergo rigorous scientific review. Scientific journals
do not publish articles until they have gone through a similar peer review
process. There is a tension inherent in biomedical research between releasing
information in a timely fashion and waiting for the peer review process to
result in a published article. Sometimes the NIH provides "late breaking
news" to the public on research findings prior to publication in scientific
journals and prior to peer review by the journals. However, when it does
so, there is an internal review process that routinely draws upon external
expertise and monitoring/advisory review boards to ensure that information
disseminated to the public summarizes the facts as they are currently known,
and that appropriate disclaimers are attached.

The policies and procedures to be followed in the preparation, review,
approval, and distribution of NIH information materials, including scientific
and professional materials, can be found in NIH Manual Chapter 1183: NIH
Publications and Audiovisuals: Preparation, Review, Approval, and Distribution
and NIH Manual Chapter 1184: Scientific and Professional Information Presented
By NIH Employees: Review, Approval, and Distribution. The procedures currently
in place were developed to be sensible, workable, flexible, and timely, and
were updated in February 2002 to better articulate OMB, HHS, and NIH information
quality guidelines. In the scientific and research context, technical information
that has been subjected to formal, independent, external peer review is generally
presumed to be of reasonable quality.

The general principles concerning the responsibilities of the NIH
research staff in the collection and recording of data, publication practices,
authorship determination, peer review, confidentiality of information, collaborations,
human subjects research, and financial conflicts of interest are exemplified
in the "Guidelines for the Conduct of Research in the Intramural Research
Programs at NIH." These guidelines can be found on the Web (www.nih.gov/news/irnews/guidelines.htm).
NIH recognizes the scientific need for replication of findings, and encourages
data sharing as appropriate. After publication, the research data, any unique
reagents, and any supporting data that form the basis of the communication
in question should be made available promptly and completely to all responsible
scientists seeking further information. Exceptions may be necessary to maintain
the confidentiality of clinical data or if unique materials were obtained
under agreements that preclude their dissemination. Investigators should
retain research data long enough to allow replication of study results --
in general, 5 to 7 years.

NIH Information Review and Approval Policies and Procedures by Type of Information

The review, approval, and dissemination of substantive scientific
information by NIH and/or its ICs require adherence to appropriate clearance
procedures set forth in NIH Manual Chapters, internal Web sites, or memos,
and are consistent with HHS and OMB guidelines. The originating office is
responsible for obtaining the necessary clearances for reproduction and distribution
of printed materials and should ensure that written material distributed
is appropriate and consistent with HHS policy.4

A document that has obtained publication clearance for paper printing
is often posted on the sponsoring IC's Web page for greater accessibility.
NIH/IC Web documents derived from IC-approved printed publications should
not need additional approvals. NIH/IC Web documents with no print counterpart
require content clearance by the appropriate IC office or contact person
to ensure that the information observes all applicable requirements governing
information for release to the public. These include the requirements provided
in NIH Manual Chapter 1183. When IC Web pages are related to more than one
IC (e.g., trans-IC publications, special interest groups), the appropriate
IC office or contact person for the primary IC responsible for creating the
Web page should be notified regarding clearance requirements.

This section describes NIH procedures and practices in place for
review and approval of substantive scientific information that is meant for
dissemination primarily to the public, and that NIH considers being subject
to the OMB Information Quality Guidelines (see Section II above).

NIH encourages professional dissemination of scientific research and
other information on behalf of public health by its employees. Professional
and scholarly writing, lecturing, editing, and publishing are an essential
part of research, are in the public interest, and bring credit and distinction
to NIH and to the employees themselves. In assisting employees to share information
about their official and professional activities, NIH seeks to advance scientific
knowledge and contribute to professional education. Ordinarily first report
of any scientific research results or other professional findings is made
by publication in a scientific or professional journal or presentation at
a meeting of a professional organization. The choice of the journal or meeting
to which reports are offered is the prerogative of the author(s).

There are many quality control measures embedded in the scientific
process to ensure that the information disseminated by NIH employees is of
the highest quality. Publications or presentations by NIH employees are expected
to meet high standards of quality, make a substantial contribution to the
field, and contain sufficient information for the informed audience to assess
its validity.

To ensure and maximize the quality of information disseminated by
NIH employees, any non-extemporaneous presentation (written or electronic)
by an NIH employee on a subject related to his/her NIH duties must be reviewed
and approved through an internal NIH process prior to submitting for publication
consideration. With few exceptions, non-extemporaneous oral presentations
on health policy or practice, or presentations with policy implications,
must also be cleared in advance. Manuscripts intended for publication are
customarily subjected to an external peer review process directed by the
interested publisher, volume editor, or journal editor.

Publication or oral presentation of scientific and professional
information by individual employees must conform to applicable laws and regulations,
including OMB Information Quality Guidelines, and the HHS Standards of Conduct
Regulations. Customary professional practices impose certain constraints
on the degree to which NIH employees may be identified with the results of
research and development work, including that obtained in collaboration with
extramural grantees.5

All Institutes have either formal or informal internal operating
procedures for identifying printing requirements and tracking publications.
These procedures come in a variety of forms such as policy issuances, internal
Web sites, memos, or annual requests for printing requirements. In addition,
the concept clearance process for new publications is often the vehicle that
Institutes use to track the development of a new publication and to identify
its attendant printing requirements. The requirements for clearance of prospective
publications are contained in NIH Manual Chapter 1183. These requirements
state that each prospective publication must be cleared through the Communications
Office within the originating NIH component and then be approved by the Office
of Communications and Public Liaison, OD/NIH and the Office of the Assistant
Secretary for Public Affairs (OASPA), HHS.

In brief, the NIH Manual Chapter 1183 requires that any official
publication (including book, bibliography, chapter of a book or textbook,
booklet, brochure, collection of abstracts, fact sheet, house organ, index,
leaflet, manual, monograph, newsletter, pamphlet, review, periodical, proceeding,
recurring report, statistical compendium, Internet document, audiovisual,
or the like), prepared by any NIH component directly or through a contract
must be sent for HHS clearance through the Editorial Operations Branch, using
form HHS-615, Publication Planning and Clearance Request. This clearance
requirement does not apply to publication of articles in journals. The authority
to permit the initial publication of articles written by NIH employees in
privately published journals, encyclopedias, and textbooks can be delegated
according to NIH Manual Chapter 1130 (Delegation of Authority).

All NIH Audio/Visual projects and exhibits must be cleared through
OASPA, whether produced in-house or under contract. To obtain clearance for
all NIH audiovisual products, including exhibits, Form HHS 524A must be completed.
It can be obtained on the Web (http://www.nih.gov/icd/od/ocpl/resources/audiovisual.htm)
and must be filed with the Office of the Assistant Secretary for Public Affairs
and approved before actual production may begin. If the cost exceeds $50,000,
a written evaluation plan is required. If more than $100,000 is involved,
a written evaluation and formal message testing are required. No subsequent
change in terms, dollar amounts, conditions, or additions can be made to
the product without written approval of OASPA.

Statistical compendiums, including statistical analyses, aggregated
information by program, IC, or for NIH, including funding information and
histories (by disease, funding mechanism, dollars, or other criteria), do
not require approval by the Office of the Director, NIH. However, the Director
of the originating IC is required to determine that the data conform to the
accepted quality standards, and if applicable, that the reported statistics
be substantially reproducible (see NIH Manual Chapter 1183).

In general, any writing by an NIH employee on a work-related subject,
whether intended for electronic or print publication, or for oral delivery,
must be prepared according to accepted NIH standards of quality, reviewed
for substantive content, and administratively approved. The purpose of the
NIH clearance process is to improve the quality of information, and to ensure
the accuracy, objectivity, utility, and validity of information. NIH Manual
Chapter 1184, states the policy and procedures to be followed in the review,
publication, and distribution of scientific, technical, and other professional
manuscripts and speeches by NIH employees. IC Directors (or their delegates)
are responsible for establishing and maintaining controls to ensure competent
and timely clearance of professional writing and presentations by developing
procedures appropriate to the type of information. They are also responsible
for maintaining files of requests for approval and actions taken. Individual
ICs may determine how best to meet these requirements.

Written presentations by intramural scientists are reviewed and
approved by Laboratory/Branch Chiefs and sometimes by Scientific Directors.
The intramural approval process also ascertains that all animal, human subjects,
and technology transfer requirements are met, that major press and policy
implications are noted, and that at least one supervisory scientist finds
the work to be of merit. (See the Intramural Research Sourcebook at www1.od.nih.gov/oir/sourcebook/oversight/pub-clear.htm).

Materials requiring review in the Office of the Director, NIH, should
be approved by a designated review officer within the originating IC, or
by a person in a supervisory relationship to the author, prior to submission
to the Office of the Director, NIH. No such preliminary review is required
for writing by an IC Director. Any statement, commentary, or discussion of
Federal policies or practices related to the employee's position or duties
that might be construed as reflecting an official position by NIH, HHS, or
the Federal Government must be approved in the Office of the Director, NIH.

For scientific and technical documents, the scientific community
recognizes peer review as the primary means of quality control. According
to OMB Information Quality Guidelines, material subjected to formal, independent,
external peer review may generally be considered to be of acceptable objectivity.
However, this presumption of objectivity is refutable based on a persuasive
showing to the contrary by a complainant in the particular instance. The
single most important determinant of a scientific review group's competence
and credibility is its members. Reviewers must have scientific excellence
(as demonstrated by their grant and publication records, and academic degrees
and honors), and must merit respect in the scientific community. They must
possess a wide breadth of expertise, be fair and objective, and should not
be influenced by inappropriate personal interests (competition, scientific
bias, personal antagonisms, and other irrelevant factors.). Reviewers should
review materials for propriety, accuracy, completeness and quality (including
objectivity, utility, and integrity).

Consistent with HHS Standards of Conduct (73.735-705 Writing and
Editing), employees are encouraged to engage in outside writing and editing
when such activity is not otherwise prohibited. If the writing or editing
activity is related to the employee's official duties or other responsibilities
and programs of the Federal Government, the employee must (i) make no mention
of his or her official title or affiliation with the Department, or (ii)
use his or her official title or affiliation with the Department and a disclaimer,
or (iii) submit the material for clearance within the operating component,
under procedures established by the component. When clearance is denied at
any lower level, the employee shall have recourse for review up to the head
of the principal operating component. This clearance will show there are
no official objections to the activity and the employee may then use his
or her official title or affiliation usually without a disclaimer. Except
where the requirement for disclaimer is waived as a result of official clearance,
disclaimers shall be used in all writing and editing related to the employee's
official duties or other responsibilities and programs of the Federal Government:
(i) in which the employee identifies himself or herself by official title
or affiliation with the Department, or (ii) when the prominence of the employee
or the employee's position might lead the public to associate him or her
with the Department, even without identification other than name. Disclaimers
shall read as follows unless a different wording is approved by the Assistant
General Counsel, Business and Administrative Law Division, Office of the
General Counsel: "This (article, book, etc.) was (written, edited) by (employee's
name) in (his or her) private capacity. No official support or endorsement
by (name of operating component or of Department) is intended or should be
inferred."

Normally, the need for a disclaimer is eliminated through the clearance
process. However, a disclaimer may still be needed even after official clearance
to clarify that the presentation should not be construed as necessarily representing
NIH views, and/or to distinguish the status of information (e.g., preliminary,
based on partial data set). The Department's regulations (Standards of Conduct)
to which the NIH subscribes, require that disclaimers be used in all unofficial
writing and editing related to the employee's official duties and/or affiliation
with programs of the Federal Government in which the employee's identification
with NIH is to be shown, can be inferred, or is well-known.

Oral information, including speeches, interviews, expert opinions,
only if representing NIH views, official positions, or policies

Any statements, comments, or discussion of Federal policies or practices
that are relevant to the employee's position or duties, draw conclusions,
advocate or oppose professional practices or positions on subjects related
to NIH duties, or might otherwise be construed as reflecting an official
position by NIH, HHS, or the Federal Government, are covered by the OMB Guidelines,
and must be approved in the Office of the Director, NIH.

An NIH employee may respond orally to questions and requests for
information from any source, including the news media, without prior review
and approval but must adhere to internal IC guidelines for informing the
IC Information Officer, Congressional Liaison Officer, or other appropriate
official about the nature of the information to be discussed. An employee
may appear as a member of a discussion panel or seminar and on radio, television,
and Web broadcasts without prior approval if the appearance does not require
a manuscript or written text or statement, and if there is no conflict with
NIH Policy as provided in Manual Chapter 1184. An employee should limit his/her
statements and responses to subjects about which he/she has official knowledge
and should present only official HHS and NIH positions in discussion of policy
matters.

No review or approval is required for nonofficial and private writing,
speaking, and publishing by an employee unless his/her NIH employment is
likely to be regarded as influencing the content.

NIH employees are responsible for the statements they make, regardless
of whether they have been cleared. If one presents material that requires
clearance but that has not been cleared prior to presentation, then the employee
must inform the audience of the personal or unofficial nature of his or her
views. An example of an appropriate disclaimer follows:

"This material is presented from my own perspective, and should not be
taken as representing the viewpoint of the Department, NIH, or [IC]."

NIH employees shall not identify themselves as NIH employees in unofficial
materials prepared for dissemination to nonprofessional audiences, such as
a letter-to-the-editor. These materials must be reviewed prior to presentation
in the Office of the Director, NIH, if an employee's identification with
NIH is to be shown, can be inferred, or is well known.

NIH Consensus Development Program

The NIH Office of Disease Prevention (ODP) manages
the NIH Consensus Development Conference (CDC) Program, the focal point for
evidence-based assessments of medical practice and state of the science on
behalf of the medical community and the public. Under this program, ODP
organizes major conferences that produce Consensus Statements and State of
the Science Statements on controversial issues in medicine important to healthcare
providers, patients, and the general public. NIH Consensus Statements and
State of the Science Statements are disseminated widely, and more than 120
NIH Consensus Statements and State of the Science Statements have been issued
since the program's inception in 1977. Organizationally, ODP is under the
Associate Director for Disease Prevention in the Office of the Director,
NIH, and works closely with NIH Institutes, Centers, and Offices to assess,
translate, and disseminate the results of biomedical research that can be
used in the delivery of important health services to the public.

An NIH Consensus Statement is a report evaluating scientific
information on a given biomedical or public health intervention with the
purpose of resolving a particular controversial issue in clinical practice.
Each NIH Consensus Statement answers a series of four to six questions concerning
efficacy, risk, and clinical applications, and recommends directions for
future research, and is the product of an NIH Consensus Development Conference.
NIH Consensus Statements synthesize new information, largely from
recent or ongoing medical research, that has implications for reevaluation
of routine medical practices. They do not give specific algorithms or guidelines
for practice.

NIH Consensus Statements are written by broad-based, independent
panels of non-Federal, non-advocate individuals knowledgeable in the field
of medical or public health science under consideration. The makeup of each
panel represents various sectors of professional and community life and typically
includes research investigators, healthcare providers, methodologists, and
a public representative.

Following circulation of the draft statement to the conference audience
for comment, the panel resolves any conflicting recommendations and releases
a revised statement at the end of the conference. The Web site for the Consensus
Development program can be found at: consensus.nih.gov.

If a suggested topic does not have an adequately defined and available
base of scientific information, conference planning and implementation may
still proceed. However, rather than being designated a Consensus Development
Conference, the conference will be designated as a State of the Science Conference.
NIH State of the Science Conferences and Workshops
generally adhere to the NIH CDC format because the process is useful for
evaluating complex issues. Usually, speakers present findings or perspectives
on the issue. The public is invited to address questions to the speakers,
and policy implications may be discussed. A report of the findings can emerge
in one of a variety of formats including publication in a clinical or scientific
journal. The Web site for the State of the Science Statements can be found
at: consensus.nih.gov.

Although it is difficult to quantify their impact, the NIH Consensus
Statements and State of the Science Statements are intended to influence
important public health discussions on topics affecting or broadly applying
to a significant number of people. The severity of the problem (morbidity
and mortality) and the feasibility of intervention are key considerations.
For example, the program has had measured success in influencing reimbursement
policy and specialty organization policy, thereby indirectly affecting physician
behavior. Each conference is jointly sponsored and administered by one or
more ICs of NIH and by ODP. Depending on the topic, other Federal agencies
with biomedical components may join in sponsoring a CDC. In conjunction with
each conference, the Agency for Health Care Research and Quality (AHRQ) provides
a systematic review of the literature on the conference topic through one
of its Evidence-Based Practice Centers.

Both the Consensus Statements and the State of the Science Statements
are independent reports of the convened panel; none are policy statements
of the NIH or the Federal Government. However, NIH funds and disseminates
the Consensus Reports, and considers these Statements to be subject to OMB's
higher standard of substantial reproducibility. These Statements meet the
OMB's quality standards because of the balanced, rigorous, and systematic
procedures that ODP has in place to develop them. The panel makes available
the evidence on which the Consensus Statement is based. If consensus cannot
be achieved, minority or alternative views are included. The systematic literature
review conducted by AHRQ is published with their explicit methods. The reports
are peer-reviewed by expert panels, and posted on the Internet for at least
one month for public comment.

Health, Safety, and Environmental Information

To make environmental health research findings more applicable to
human risk assessment, NIH works in partnership with the CDC and the EPA
to develop better ways to monitor and assess human exposure to specific chemicals.
One of our most visible publications is the Report on Carcinogens (RoC),
a congressionally mandated document that lists agents, substances, mixtures
or exposure circumstances that are known or reasonably anticipated to be
human carcinogens, and to which a significant number of persons residing
in the United States are exposed. Responsibility for producing this report
has been delegated to the National Toxicology Program (NTP) and the Director
NTP also serves as the Director, NIEHS, NIH.6
The RoC is a composite of Summary Profiles that describes the carcinogenicity,
exposure, and regulatory information for each listing with relevant tables
and appendices. The NTP follows a published, multi-step process to review and
evaluate selected substances and to develop the NTP’s recommendations to the
Secretary, HHS, regarding whether or not the substances should be listed in the report.

Upon review and approval by the Secretary, HHS, and submission to Congress, a notice
of the RoC publication, indicating all newly listed or de-listed agents,
substances, mixtures or exposure circumstances is published in the Federal
Register, NTP newsletters and web pages and other appropriate publications.
The current review process was finalized and released to the public on January 11, 2012
[http://ntp.niehs.nih.gov/go/rocprocess].

It is important to note that the RoC does not present assessments
of carcinogenic risks. Listing of substances in this Report, therefore, does
not establish that such substances present carcinogenic risks to individuals
in their daily lives. Such formal risk assessments are the purview of the
appropriate Federal, State, and local health regulatory and research agencies.
However, for each effluent, ambient, or exposure standard established by
a Federal agency with respect to a listed substance, the RoC is required
to state the extent to which, on the basis of available medical, scientific,
or other data, the implementation of such standard decreases the risk to
public health from exposure to the substance. This requires quantified information
on the extent of protection from cancer that the public receives from established
Federal standards. Only in a few instances, where studies of long-term human
exposures and cancer incidence in restricted environments are available,
can risk be estimated with complete confidence.

NIEHS and NTP procedures conform to accepted NIH scientific practices
where quantitative and qualitative scientific conclusions are based on: (1)
The best available science and supporting studies, particularly peer-reviewed
studies, conducted in accordance with sound and objective scientific practices;
and (2) data collected by accepted methods or best available methods (if
the reliability of the method and the nature of the decision justifies use
of the data). The NIEHS and NTP make every effort to ensure that the presentation
and dissemination of information about environmental health is comprehensive,
informative, and understandable.

Scientific results that can directly affect risk assessment and
risk management activities are often published in the NIEHS journal Environmental Health Perspectives
(EHP), but do not necessarily represent the viewpoints of NIEHS. EHP also
publishes perspectives in the form of editorials, commentaries, reviews,
and correspondence, as well as workshop summaries. Workshop summaries are
reports by expert scientific committees that include reviews of existing
information and that summarize research findings on specific topics, present
new information, and recommend methods, courses of action, or further research
needs for the scientific community. All scientific articles, including workshop
summaries, are subject to rigorous peer review. The criteria for publication
are weighted toward scientific quality and environmental significance. A
submission is assessed according to its originality, scientific merit, and
experimental design; the manuscript is evaluated for its conciseness, clarity,
and presentation. These standards are thus consistent with the requirement
that the presentation of information on risk effects be comprehensive, informative,
and understandable. EHP also addresses certain ethical problems during the
review process and requires assurances that all human and animal subjects
have been treated humanely and with regard for the alleviation of suffering.
The review also considers scientific integrity as part of the process.

NIH Clearinghouse Information

Clearinghouses often serve as the public's point of contact and access
to information about IC programs, conferences, and research activities. At
NIH, clearinghouses have been contracted to provide varying levels of service,
including development and distribution of fact sheets, information packages,
and publications; storage of materials; conducting outreach and promotion;
and performing training and quality control for the clearinghouse staff.
Some clearinghouses respond to inquiries about particular diseases or conditions,
ranging from information about available patient and professional education
materials to statistical data. Clearinghouses are challenged to ensure accuracy
and reliability of information, while continually striving to improve performance
and response times. Some clearinghouses also wrestle with how to determine
which organizations are worthy of referral when customers need information
that is not available at the clearinghouse and how to avoid implying endorsement.
Clearinghouse inquiries may also be answered by searching the Combined Health
Information Database (CHID), an NIH/CDC database that provides bibliographic
references of both NIH and non-NIH materials on various health topics. This
database represents a shared data archive, and as such is not covered by
the new OMB guidelines.

The NIH Manual chapter 1183 requires that official materials or
information prepared by any NIH component directly or through a contract
must be sent for HHS clearance through the Editorial Operations Branch, using
form HHS-615, Publication Planning and Clearance Request. This clearance
requirement does not apply to publication of articles in journals. Information
developed by a clearinghouse for an NIH IC is subject to the OMB Guidelines.
See NIH Manual Chapter 1183 for further information regarding this requirement.

At NIH, there are essentially three types of materials being disseminated
through information clearinghouses to the public: (1) Materials produced
by NIH staff or contractors that undergo usual NIH review and approval processes;
(2) materials produced by NIH grantees that are subject to policies and procedures
in the Public Health Service (PHS) Grants Policy Statement; and (3) other
materials not produced by NIH but available through libraries, whether in
print or in electronic format, with appropriate disclaimers attached. Virtually
all NIH ICs direct their clearinghouses to distribute only materials produced
by the IC or other NIH ICs or Federal agencies. Non-Federal materials typically
undergo careful IC scientific review before they are authorized for dissemination
by the clearinghouse, and those materials are accompanied by appropriate
disclaimers.

Procedures to Ensure the "Integrity" of Information

NIH has developed World Wide Web (WWW) Guidance (April 15, 1998), which is available on the Internet (http://ocio.nih.gov/docs/policy/guideli2.html).
Each IC has a designated IC contact/reviewer for information and approvals
related to developing Web pages and operating a new Web server. The list
of IC contacts/reviewers is available on the website (www.nih.gov/employee/weblist.htm). NIH/IC Web page creators periodically
review material on the Web page to determine whether it is accurate and up
to date. Information, particularly time-sensitive information, should be
posted as soon as possible. Web page creators are expected to promptly update
or remove out-of-date information.

Unless noted otherwise, it is safe to assume that information posted
on public Web sites within the "NIH.GOV" domain is considered to be "in the
public domain." As such, others are free to establish links to NIH online
resources. In establishing such links, NIH requests that others avoid creating
the impression that NIH is endorsing or promoting any particular product
or service. In the same vein, any outside link to an external resource from
an NIH Web site needs to be examined on a case-by-case basis. In general,
the Web developer of each site determines when links to outside entities
are justified.

NIH Web managers are urged to exercise caution when linking to non-NIH,
external websites. Professional judgment should be used to weigh the benefits
against the possible risks of linking to other resources. In particular,
links to sites providing medical and scientific information needs to be on
par with the standards used at NIH to ensure the credibility of the information
offered there. Steps should be taken to ensure that such links do not give
the impression of endorsing the organizations we link to. NIH/IC Web pages
containing links to external Web pages not located on NIH servers should
include a link to a statement that releases NIH from responsibility for the
material included in the external Web page. Again, it is important to avoid
giving a user the impression that NIH is endorsing information or a commercial
product described in an external site. Disclaimers on copyright, endorsement
(general and external links), liability, and medical information are also
used, as appropriate, for individual IC Web sites.

The IC designates a main office or contact person for information
and approvals related to Web pages and the operation of Web servers. NIH
personnel, contractors, and other authorized users of NIH networks must notify
this office or contact person prior to setting up a Web server. Information
about appropriate security measures regarding Web Servers is available at:
http://ocio.nih.gov/security/sec_policy.html.
The IC or the OD Information Office can provide detailed information on required
approvals including both NIH and IC-specific policies relating to publication
of documents. NIH/IC documents derived from IC-approved printed publications
should not need additional approvals (see Section V.2).

The NIH Center for Information Technology (CIT) is charged with providing,
coordinating, and managing information technology for NIH, and with advancing
computational science. In terms of computer security, CIT has three distinct
objectives: Confidentiality -- ensuring that there is no deliberate or accidental
improper disclosure of sensitive automated information; integrity -- protecting
against deliberate or accidental corruption of automated information; and
availability -- protecting against deliberate or accidental actions that
cause automated information resources to be unavailable to users when needed.
Information is accorded protection against disclosure, alteration, loss,
or destruction based on the degree of sensitivity.

CIT staff use appropriate safeguards to protect data from improper
disclosure by backing up critical data periodically, and, if a security incident
occurs, by following proper incident response procedures. In 1994, CIT adopted
a security incident response policy and procedures statement that establishes
the responsibilities of CIT staff in responding to and reporting computer
security problems. Supervisors are responsible for ensuring that employees,
both Government and contractor, observe all security requirements, and that
employees receive appropriate security training.

CIT has instituted a structured management control review process
that applies throughout the system life cycle. Risk analyses are conducted
to strike a balance between an acceptable level of risk and the costs and
inconvenience associated with safeguards. A system recertification/accreditation
must be conducted at least once every 3 years. Additional information about
NIH computer security measures can be found in The Computer Security Handbook
of CIT (http://ocio.nih.gov/security/sec_policy.html).

VI. Agency Administrative Complaint Procedures

NIH has developed administrative procedures to allow affected persons
to seek and obtain correction of disseminated information that does not comply
with OMB, HHS, and NIH guidelines (See NIH Manual Chapter 1185).
Additional guidance on appropriate responses can be obtained from the NIH website
(http://ospa.od.nih.gov/infoquality.html),
particularly if the complaint involves a policy statement or official position.
NIH established this website to advise information consumers of the agency's
information quality guidelines, the process to submit a request for correction,
information needed by the requestor, and a description of the complaint adjudication
process.

The resolution process addresses the valid needs of the complainant
without disrupting NIH processes. Complainants should be aware that they
bear the "burden of proof" with respect to the necessity for correction,
as well as with respect to the type of correction they seek. In making a
determination of whether or not to correct information, NIH may reject claims
made in bad faith or without justification, and is required to undertake
only the degree of correction that is appropriate for the nature and timeliness
of the information involved.

Responsibility of the Complainant

To seek a correction of information disseminated by the NIH or its components,
an individual should submit or mail the request to the disseminating office
(contact information for individual ICs will be made available through the
NIH Information Quality website), or submit the request by electronic mail
(email) to InfoQuality@mail.nih.gov or
InfoQuality@od.nih.gov or mail the complaint to:

The request should state that an information quality request for correction
is being submitted, and should provide the following information:

A detailed description of the specific material that is proposed for
correction, including where the material is located, i.e., the publication
title, date, and publication number, if any, or the website and web page
address (URL), or the presentation, presenter, date and mode of delivery;

The specific reasons for believing that the information does
not comply with OMB, HHS, or NIH guidelines and is in error, and supporting
documentation, if any;

Suggested recommendations for what corrective action(s) should be taken;

A description of how the person requesting the correction is affected by the information error; and

Requests for correction should be handled primarily by the originating
IC Director or designee (e.g., Scientific Director, Laboratory or Branch
Chief). IC Directors are responsible for establishing and maintaining procedures
to ensure that requests are properly addressed, that an objective and qualified
review of the merits of the request is undertaken, and that an appropriate
response is provided in a timely manner. The procedures may include forming
a review committee or equivalent, and shall allow for response by the originating
and contributing authors, as well as input from the IC Communications Director.

A complaint about information originating from a division or office
within the Office of the Director (OD), NIH, should be addressed by the director
of the division or office, with input from the Office of Science Policy and Office of Communications and
Public Liaison (OCPL), OD, NIH.

If more than one IC was involved in releasing the information, the
IC of the lead NIH author should take primary responsibility for coordinating
a response.

Appropriate Responses

Based on a review of the information provided, the responding office
should determine whether a correction or clarification is warranted and if
so, what action to take. Agencies may choose not to change claimed defects
that are frivolous or unlikely to have substantial future impact. If NIH
determines that action is warranted, NIH may respond in any of the following
ways:

Provide a clarification by personal contact via letter or telephone;

Issue a written retraction or clarification, which can be accomplished
through a press release, mass mailing, or some other reasonable method that
corrects a widely disseminated error or addresses a frequently raised complaint;

Suspend further dissemination of the information in question;

Refer complainant to the underlying data if the data are available in a public archive;

Arrange for an independent reanalysis of the data by NIH or
a mutually acceptable third party if the data are not publicly available,
and the complaint involves "influential scientific or statistical information."
Complainants must agree to pay the costs of reanalysis or the process terminates.

Work with the grantee institution to respond to the complaint,
when it involves research from a grantee. Complaints must be about information
derived from a project that is supported in whole or in part with Federal
funds under a new or competing continuation grant awarded after April 17,
2000, and that is cited officially by a Federal agency in support of an action
that has the force of law, such as a new regulation or administrative order.
(If not available elsewhere, these types of data can be obtained from a FOIA
Coordinator for the granting IC, see www.nih.gov/icd/od/foia/coord.htm. Additional information about NIH FOIA procedures, including requests, appeals, and fees, is available at www.nih.gov/icd/od/foia/. For NIH guidance on OMB Circular A-110 see grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm).

The response to the complainant will be by letter or email, and should
explain the findings of the NIH review of the merits of the complaint, and
the actions to be taken, if any. The response should consider the nature
and timeliness of the information involved and such factors as the significance
of the correction on the use of the information and the magnitude of the
correction. The response should also describe how the complainant may request
reconsideration. NIH will respond to all requests for corrections within
60 calendar days of receipt. If the request requires more than 60 calendar
days to resolve, the responsible official will inform the complainant that
more time is required and indicate the reason for the delay and an estimated
decision date.

Whether or not corrective action is warranted, the response to the
complainant should describe the preparation, clearance, review, and approval
process prior to the information being disseminated, including any specifics
about the peer review process to support the rigor and objectivity of the
review, e.g., the breadth and depth of experts, community input, and message
testing. The response should also reiterate any disclaimers that accompanied
the information when it was first released.

Additional guidance on appropriate responses can be sought from
the OSP, or OCPL, OD, NIH, particularly if the complaint involves a policy statement
or official position.

Reporting Requirements

The IC (or OD office) receiving a request for information correction
is required to enter the complaint into the NIH tracking database for this
purpose. The IC is encouraged to contact OSP, OD, NIH to discuss the nature
of the complaint, and to provide a preliminary assessment of whether the
complaint is legitimate. Among the criteria to be used:

The information is considered official NIH information, i.e., approved
through the NIH clearance process and intended to represent the views of
NIH.

The information is substantive (i.e., reports, studies, summaries) rather than pertaining to basic agency operations.

The information was disseminated on or after October 1, 2002

The information is not exempt according to Section C (Applicability) of this chapter.

The complainant is someone who may benefit or be harmed by the disseminated
information. This includes persons who are seeking to address information
about themselves as well as persons who use information.

If the IC determines that corrective action is warranted, the IC shall
forward the following information to the OSP and OCPL, OD, NIH without delay:

A copy of the complaint.

A list of the relevant contacts within the NIH IC or OD office,
including the names of those most knowledgeable about the information in
question.

A draft letter response with any supporting documentation.

OSP and OCPL responsibilities include:

Assisting with the review of the complaint for legitimacy. If the complaint
is later determined not to be legitimate, the IC must provide a clear explanation
of the rationale for that determination to the complainant.

Reviewing the proposed IC response for appropriateness, and assisting in finalizing the response.

Maintaining a tracking database of complaints, including information
on their disposition and any resolution or corrective action taken.

Submitting an annual report on behalf of NIH to the Department
of Health and Human Services (HHS) with the number and types of complaints,
and the action taken, in time for the HHS to report to OMB by January 1 (beginning
in 2004).

Posting on the OSP Web site any further clarifications, guidelines,
and Frequently Asked Questions (FAQs) about handling NIH information complaints.

Making examples of typical complaints and appropriate responses available to ICs.

Appeals

If NIH denies a request for correction, the complainant may send
within 30 days of receipt of the agency's decision a written request for
reconsideration. The request should state the reasons for the appeal and
may be sent as hard copy or electronically to InfoQuality@od.nih.gov.
Requestors should reference the NIH tracking number provided in the NIH
response to the original request. If sent by hard copy, requestors should
also clearly mark the appeal and the outside envelope, "Information Quality
Appeal," and send the appeal to the following address:

Any office that originally disseminated the information and/or responded
to the original complaint should not have responsibility for the resolution
of the appeal. If the information in dispute was originally disseminated
by the NIH, then an appeal should be addressed to the NIH Director at
the address listed above, or sent electronically to InfoQuality@od.nih.gov.

NIH will respond to all requests for appeals within 60 calendar days
of receipt. If the request requires more than 60 calendar days to resolve,
the agency will inform the complainant that more time is required and indicate
the reason for the delay and an estimated decision date.

VII. Influential Scientific, Financial, and Statistical Information

The OMB Information Quality Guidelines require that "influential" scientific,
financial, or statistical information in official Government documents must
be based on studies that can be substantially reproduced if the original
or supporting data were to be independently reanalyzed using the same methods.
"Influential" when used in the phrase "influential scientific, financial,
or statistical information" means that the NIH can reasonably determine that
dissemination of the information will have or does have a clear and substantial
impact on important public policies or important private sector decisions,
or will have important consequences for specific health practices, technologies,
substances, products, or firms." NIH is committed to applying rigorous scientific
standards to ensure the accuracy, reliability, and reproducibility of research
results.

The reproducibility standard applies to analytic results and not necessarily
to the original and supporting data used to produce the analytic results.
To facilitate the replication of scientific and other influential information
by qualified third parties, NIH continues to encourage the sharing of original
data and methods where practicable. After publication, the research data,
any unique reagents, and any supporting data that form the basis of any research
communication should be made available promptly and completely to any person
who seeks further information.

Since the influence and implications of NIH-disseminated information
cannot always be fully anticipated, all NIH scientific reports are expected
to state clearly how analytic results are generated -- the specific data
used, various assumptions, specific analytic methods, statistical procedures,
sources of error -- making the analysis sufficiently transparent so as to
be capable of being reproduced. NIH advocates the archiving of data where
feasible to facilitate the reproducibility of influential information. Exceptions
may be necessary to maintain the confidentiality of clinical data or if unique
materials were developed or obtained under agreements that preclude their
dissemination. Investigators should retain research data long enough to allow
replication of study results -- in general, 5 to 7 years. In situations where
public access to underlying data is not practicable, NIH shall apply especially
rigorous robustness checks to analytic results and document what checks were
undertaken.

Examples of the types of information disseminated by NIH that have
the potential of being considered influential and that fall within the scope
of the OMB Guidelines include:

NIH Consensus Statements

NIH Research Reports

NIH Recommendations about Health Practice or Medical Treatment

NIH Funding for Research Areas of Interest

For scientific and technical documents, the scientific community recognizes
peer review as the primary means of quality control. NIH routinely seeks
input from qualified peer reviewers of influential materials for propriety,
accuracy, completeness, and quality (including objectivity, utility, and
integrity) prior to dissemination. Although concerted efforts are made to
ensure that influential information be subjected to rigorous peer review
and reproducibility specifications, standard operating procedures may be
temporarily disrupted under urgent situations, such as when an imminent threat
to public health or homeland security is identified.

With respect to health, safety, and environmental information, NIH
does not have a mandate to conduct formal risk assessments, which are the
purview of the appropriate Federal, State, and local health regulatory and
research agencies (see Section V.2.iv). NIH makes every effort to ensure
that the presentation and dissemination of information about environmental
health is comprehensive, informative, and understandable, and that scientific
conclusions are based on: (1) The best available science and supporting studies,
particularly peer-reviewed studies, conducted in accordance with sound and
objective scientific practices; and (2) data collected by accepted methods
or best available methods (if the reliability of the method and the nature
of the decision justifies use of the data).

VIII. Special Considerations for Agency Dissemination

Sometimes
NIH provides "late breaking news" of urgent import to the public on research
findings prior to publication in scientific journals and prior to peer review
by journals. Under such special circumstances, NIH may temporarily waive
adherence to information quality guidelines. However, when it does so, there
is an internal review process that routinely draws upon external expertise
and relevant monitoring or advisory boards to ensure that information disseminated
to the public summarizes the facts as NIH currently knows them, and that
appropriate disclaimers are attached.

IX. References

Guidelines for the Conduct of Research in the Intramural Research Programs at the National Institutes of Health, 3rd edition, January 1997 (for a discussion of publication practices and authorship issues.) www.nih.gov/news/irnews/guidelines.htm

Office of Management and Budget Guidelines for Ensuring and Maximizing
the Quality, Objectivity, Utility, and Integrity of Information Disseminated
by Federal Agencies. Final Guidelines. February 22, 2002 www.whitehouse.gov/omb/fedreg/reproducible2.pdf

In general, grantees own the data generated by or resulting from a grant-supported
project. Special terms and conditions of the award may specify alternative
rights, e.g., under a cooperative agreement or if there are shared rights
to data. Except as otherwise provided in the terms and conditions of the
award, the grantee is free to copyright without NIH approval when publications,
data, or other copyrightable works are developed under, or in the course
of, work under an NIH grant. For this purpose, "data" means recorded information,
regardless of the form or media on which it may be recorded, and includes
writings, films, sound recordings, pictorial reproductions, drawings, designs,
or other graphic representations, procedural manuals, forms, diagrams, work
flow charts, equipment descriptions, data files, data processing or computer
programs (software), statistical records, and other research data. Grantees
are required to place an acknowledgment of NIH grant support and a disclaimer,
as appropriate, on any publication written or published with such support
and, if feasible, on any publication reporting the results of, or describing,
a grant-supported activity. An acknowledgment shall be to the effect that:
"This publication was made possible by Grant Number ________ from _________"
or "The project described was supported by Grant Number ________ from ________"
and "Its contents are solely the responsibility of the authors and do not
necessarily represent the official views of the (name of awarding office
or NIH)." For more details, see the NIH Grants Policy Statement.

RePORTER is a searchable database of federally funded biomedical
research projects conducted at universities, hospitals, and other research
institutions. The database, maintained by the Office of Extramural Research
at NIH, includes projects funded by NIH, Substance Abuse and Mental Health
Services (SAMHSA), Health Resources and Services Administration (HRSA), Food
and Drug Administration (FDA), Centers for Disease Control and Prevention
(CDC), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant
Secretary of Health (OASH). Users, including the public, can use the RePORTER
interface to search for scientific concepts, emerging trends and techniques,
or identify specific projects and/or investigators.

Excluded from this discussion are non-work-related and private
writing, speaking, and publishing by an NIH employee, unless the employee's
NIH responsibilities are likely to be regarded as influencing the content.

NIH Manual Chapter 6308 (Acquisition of Printing Requirements
at the NIH) sets forth guidelines on how requirements for printing are to
be handled by ICs at the NIH, in compliance with Federal printing rules and
procedures. Manual Issuance 6308 covers direct acquisition for printing,
as well as printing that is a peripheral deliverable in a contract for a
larger purpose (e.g., an R&D contract for a study, the results of which
are to be published).

To merit approval for (co-)authorships on publications from
extramural awards (including grants, contracts, and other award mechanisms),
NIH staff must have played a substantial role beyond normal program officer
duties, including the following:

Originating the specific ideas that led to the research activity and manuscript,

Performing significant portions of the activity, and

Participating actively in preparing manuscripts.

The conditions allowing NIH staff to be (co-)authors of publications
under NIH extramural awards ordinarily arise only from contracts and cooperative
agreements, where, by definition, there is substantial programmatic, i.e.,
scientific-technical, staff involvement. Deviations from these provisions
must be approved by IC directors, and only when justified under special circumstances.
The Office of Extramural Research, OD, can provide further information and
advice on this subject.

The National Toxicology Program (NTP) was established in 1978
by the Department of Health and Human Services (HHS) to coordinate toxicological
testing programs within the Department, strengthen the science base in toxicology;
develop and validate improved testing methods; and provide information about
potentially toxic chemicals to health regulatory and research agencies, the
scientific and medical communities, and the public. NTP's mission is to evaluate
agents of public health concern by developing and applying tools of modern
toxicology and molecular biology. The NTP is an interagency program consisting
of relevant toxicology activities of the National Institutes of Health's
National Institute of Environmental Health Sciences (NIH/NIEHS), the Centers
for Disease Control and Prevention's National Institute for Occupational
Safety and Health (CDC/NIOSH), and the Food and Drug Administration's National
Center for Toxicological Research (FDA/NCTR). The NIH's National Cancer Institute
(NIH/NCI) was a charter agency; however, the NCI Carcinogenesis Bioassay
Program was transferred to the NIEHS in 1981. The NCI remains active in the
Program through membership on the NTP Executive Committee.